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How Voluntary Is FDA’s New Voluntary Labeling?


How Voluntary Is FDA’s New Voluntary Labeling on Produce?

Just before Thanksgiving CDC made an announcement to consumers not to eat romaine lettuce. This was the second time that I am aware of that there has been a commodity-wide “do not eat” announcement from the federal government. The last time such an announcement was made was in 2006 in relation to spinach.


At the time of the announcement there was an on-going outbreak of E. coli O157:H7, which has, thus far, resulted in 43 illnesses in 12 states and 22 in Canada that was epidemiologically linked to lettuce. There is little doubt that the announcement stopped the outbreak – assuming it was indeed due to romaine! However, the announcement also will have cost the produce industry at all levels – from grower to retail and food service – tens of millions of dollars.


While the FDA, CDC, state and Canadian authorities were investigating the romaine lettuce outbreak, the industry was scrambling to get some romaine back on the market. The government is allowing that but with a twist. This time, they are taking it a step further – and it’s a step that the food industry needs to take heed of, because it is already impacting all leafy greens and is likely to continue a forward trajectory to other produce (and potentially ingredients as a whole?).


That step is the “voluntary labeling” of all romaine lettuce. I put that in quotes because FDA is citing it as voluntary, but a statement from FDA Commissioner Scott Gottlieb said, “Based on discussions with major producers and distributors, romaine lettuce entering the market will now be labeled with a harvest location and a harvest date.”


First, note that it says “will now be labeled.” This doesn’t sound very voluntary, though the sentences seem to indicate that it’s the major producers and distributors committing to it. But, of even greater importance is the sentence to consumers that follows: “If it does not have this information, you should not eat or use it.” Again, FDA is not mandating it; rather it is telling consumer to avoid unlabeled romaine through their purchasing. I’d say putting the enforcement in the hands of consumers is a pretty sly way of mandating without regulating.


The decision was not made behind closed doors at FDA headquarters, either. Rather, as noted above, FDA discussed the outbreak issues and product labeling and dating with the major producers and distributors of romaine lettuce in the U.S. and with the major trade associations representing the produce industry. From these discussions:


  • The romaine lettuce industry committed to continuing the labeling into the future to become the standard for their products.

  • The leafy greens industry agreed to establish a task force to find solutions for long term labeling of romaine lettuce and other leafy greens. It also will analyze the outbreak and its cause to determine how to prevent ongoing safety problems with romaine lettuce.

In his statement, Gottlieb also said, “One outcome could be to extend the commitment for labeling for origin and date of harvest to other leafy greens.” If that happens (which it likely will), why would it stop with leafy greens? Particularly when you note his more inclusive statement that: “Knowing the growing origin of produce will continue to play an important role in allowing consumers to avoid contaminated products and facilitating market withdrawals and tracebacks.”


Thus, the precise wording from FDA is that of “urging” growers, processors, distributors and retailers to:

  • clearly and prominently label all individually packaged romaine products to identify growing region and harvest date for romaine; and

  • clearly and prominently label at the point of sale the growing region when it is not possible for romaine lettuce suppliers to label the package (e.g. individual unwrapped whole heads of romaine lettuce available in retail stores).

When one considers the number of outbreaks that have taken months to trace back to their source, or were originally misidentified, or were never completely traced back at all, I would see this labeling as a beneficial move, particularly for produce and high-risk ingredients. And if you would need to justify related time and expenses to your C-Suite – beyond the sheer aspects of consumer safety – simply relate FDA’s statement to consumers: “If it does not have this (labeling) information, you should not eat or use it.”


Consumers have become increasingly focused on the transparency of the food industry; on what is in their food, how it is produced, and where it is from. They are reading labels. They are telling their friends – which, through social media – has become vastly broader than the old adage that “unhappy customers will tell 10 friends.”


So, whether your business is produce of any sort, or you simply use produce in your product – which covers a large proportion of the food industry – I would urge you start looking at your supply chain now. Preventive controls are key in growing and making safe food, but the unpredictable does happen. So, prevention without traceability to quickly identify a source is only half the solution.


One-forward/one-back may be the law, but it is no longer enough. How many of your ingredients can you trace all the way back to the source? You may think this is a costly endeavor, but what might be your costs of not knowing?


The new labeling initiative is a step in the right direction; but it is just that – a step. There is a lot more that needs to be done from the grower to the point of sale for the produce industry. Historically, change has been too costly for the produce industry, but if the government is in a mood to make commodity-wide “do not eat” statements, the costs of those will soon far outweigh the cost of change.


As a final thought, I do wonder whether the motive for the pre-Thanksgiving announcement was really all about protecting public health, or was it a strong message to the produce industry that three outbreaks linked to romaine in the recent past is just too much, and it is time for change in the industry. I think it was both, and only time will tell if the industry – and by that I mean grower to point of sale to consumer – is ready to invest in change.


About The Acheson Group (TAG)

Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG's team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.achesongroup.com

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